Whole-Genome MRD Test Detects Early Recurrence in Muscle-Invasive Bladder Cancer

Bladder cancer is among the most common malignancies in the United States, with about 85,000 new cases each year. The muscle-invasive form accounts for roughly one quarter of diagnoses and carries a high risk of recurrence within two years after treatment, while routine surveillance relies largely on imaging that may miss early relapse. Timely molecular detection could support earlier intervention. A newly launched test now provides Medicare-covered, whole-genome monitoring for recurrence after curative-intent therapy in muscle-invasive bladder cancer.

Veracyte’s (South San Francisco, CA, USA) TrueMRD Monitoring Test has received coverage from the Centers for Medicare & Medicaid Services’ Molecular Diagnostics Services Program (MolDX) for recurrence monitoring following definitive treatment with curative intent in patients with muscle-invasive bladder cancer (MIBC). The decision marks the first Medicare coverage determination for Veracyte’s whole-genome sequencing-based TrueMRD platform and the commercial launch of the company’s first molecular residual disease (MRD) offering. The coverage is intended to enable access to recurrence monitoring for eligible Medicare beneficiaries with MIBC.

Image: TrueMRD uses a whole-genome, tumor-informed approach that analyzes patient-specific tumor variants across the entire genome in every sample tested (photo courtesy of Veracyte)

TrueMRD uses a whole-genome, tumor-informed approach that analyzes patient-specific tumor variants across the entire genome in every sample tested. This methodology contrasts with approaches that track a limited set of genetic targets. The platform enables longitudinal assessment of tumor clonality and molecular evolution, which may be important for patients who initially respond to therapy but subsequently experience recurrent disease.

Clinical evidence supporting the platform includes PAGER, a pivotal prospective study published in European Urology. The study evaluated more than 900 blood and tissue samples from 112 patients with MIBC who received neoadjuvant chemotherapy and radical cystectomy. In this study, the TrueMRD Monitoring Test detected disease recurrence a median of 131 days earlier than imaging.

The platform is also being used in ongoing research in MIBC. The TOMBOLA trial is evaluating circulating tumor DNA (ctDNA)-guided use of adjuvant immunotherapy with checkpoint inhibitors. The NEO-BLAST trial aims to spare patients from unnecessary surgery by investigating whether those with no remaining cancer after neoadjuvant therapy can safely opt for active surveillance rather than immediate radical cystectomy.

"Surveillance for muscle-invasive bladder cancer relies heavily on imaging right now, which has real limitations in detecting early recurrence. A whole-genome MRD test that can help identify disease recurrence, often months before imaging, gives clinicians a powerful new tool," said Matthew Galsky, M.D., Professor of Medicine, Icahn School of Medicine at Mount Sinai and Deputy Director, Mount Sinai Tisch Cancer Center. 

"The expanding clinical evidence behind Veracyte’s MRD platform is compelling, and Medicare coverage brings this test to patients at a pivotal time when the landscape of treatment for muscle-invasive bladder cancer is rapidly changing with the development of more effective systemic therapies and expanding bladder-sparing approaches,” said Dr. Galsky

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